Measuring Outcomes In Patients With Pulmonary Arterial Hypertension Not on Active Treatment (MOTION)

Completed · Phase 4

Conditions studied: Hypertension, Pulmonary

In brief

The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial Hypertension (PAH). The study was designed to further explore patient-reported outcomes in PAH subjects who were not on active treatment and living in the United States. In addition, the study explored the use of new telemetric technology (Accelerator band) to evaluate if this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients with PAH.

Key facts

Study ID

NCT02191137

Run by

Bayer

People needed

75

Starts

2014-09-23

Expected to finish

2016-07-16

Last updated by the study team

2017-10-13

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients, 18 to 80 years of age at Visit 0
• Women of childbearing potential must have a negative pre-treatment pregnancy test, negative monthly pregnancy test, and must use reliable methods of contraception according to the Risk Evaluation Mitigation Strategies (REMS) guidance
• Symptomatic pulmonary arterial hypertension, World Health Organization Group 1 with a pulmonary vascular resistance (PVR) >300 dyn*sec*cm-5, mean pulmonary artery pressure (PAP mean) ≥25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤15 mmHg as assessed by right heart catheterization within 6 months prior to Screening (Visit 0)
• PAH of the following types:
• Idiopathic (IPAH) Familial (FPAH)
• Associated with PAH (APAH) due to:
• Connective tissue disease Congenital heart disease, but only if patient underwent surgical repair more than one year before enrollment Anorexigen or amphetamine use Portal hypertension with liver cirrhosis
• Not treated with PAH-specific pulmonary medications within 14 days of Screening (Visit 0)
• 6MWD between 150 meters and 450 meters

You may not qualify if…

• Patients who are pregnant
• Patients currently on nitrate and/or nitric oxide (NO) donor therapy; patients currently taking phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific PDE inhibitors (theophylline, dipyridamole)
• Non-WHO group 1 Pulmonary Hypertension
• Severe restrictive lung disease
• History of uncontrolled high blood pressure or hypotension
• A medical disorder, condition, or history that in the opinion of the Investigator would impair their ability to participate or complete this study
• Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization

Where it is running

• Study site — La Jolla, California, United States
• Study site — Moreno Valley, California, United States
• Study site — Pomona, California, United States
• Study site — Sacramento, California, United States
• Study site — San Juan Capistrano, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Celebration, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Weston, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Augusta, Georgia, United States
• Study site — Austell, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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